News and press releases
Shaping regulatory science to 2025, , 17/10/2018
Wed, 17 Oct 2018 12:50 +0100

EMA is hosting a workshop on Wednesday, 24 October to gather insight from stakeholders on the key areas in human medicines to be covered in its ‘Regulatory Science Strategy to 2025’, a proposed new high-level plan for advancing its engagement with regulatory science.

The workshop will offer an opportunity to reflect on the scientific and technological advances in the pharmaceutical arena, the challenges that the Agency’s scientific committees and working parties will face in the future and to look at initial proposals to address them. It will also highlight areas relevant to various stakeholder groups in advance of a six-month public consultation on the proposed strategy to be launched in December 2018.

“The pace of innovation has accelerated dramatically in recent years and regulators need to be ready to support the development of increasingly complex medicines that more and more deliver healthcare solutions by converging different technologies to promote and protect human and animal health,” said Guido Rasi, EMA’s Executive Director. “Also, big data will open up new sources of information on the use of medicines in the real word, and we need to take urgent action to address the challenges arising from collecting and processing this personal data from patients. This will inform the network’s regulatory science strategy and help us to keep on top of developments, identify the gaps between science and healthcare systems and bring together the various stakeholders needed to bridge those gaps.”

An for the workshop is available. Participants will include patients, healthcare professionals and academia, as well as representatives of health technology assessment (HTA) bodies, payer organisations, trade associations and regulators. The workshop will kick off discussions on how to best reshape the regulatory environment so that EMA, working as part of the European medicines regulatory network, can support advances coming through research and development pipelines in the coming years.

The workshop can be followed live in the ‘multimedia’ section on the event page.

Key priorities of the Regulatory Science Strategy to 2025

The ‘Regulatory Science Strategy to 2025’ will identify key areas where new or enhanced engagement of the network is essential and where advances in regulatory science will need to be adopted.

The strategy will help shape the vision for the next EU Medicines Agencies Network Strategy (2020–2025). It will seek to offer informed guidance on modern product development, facilitate the optimisation of regulatory tools to improve the various processes and critically assess the benefits and risks of innovative therapies and diagnostics based on new technologies.

The five key goals of the strategy include:

  • catalysing the integration of science and technology in medicine development;
  • driving collaborative evidence generation -  improving the scientific quality of evaluations;
  • advancing patient-centred access to medicines in partnership with healthcare systems;
  • addressing emerging health threats and availability/therapeutic challenges;
  • enabling and leveraging research and innovation in regulatory science.

A workshop to discuss how veterinary medicines will be covered in the regulatory science strategy will take place at EMA on Thursday, 6 December 2018. More details on this workshop will be communicated shortly.

The presentations and recordings of both workshops will be published.

Participants are encouraged to tweet using the following hashtag: #RegScience2025.

Note

  • Regulatory science is defined as the range of scientific disciplines that are applied to the quality, safety and efficacy assessment of medicinal products and that inform regulatory decision-making throughout the lifecycle of a medicine. It encompasses basic and applied biomedical and social sciences and contributes to the development of regulatory standards and tools.
Regulatory information – adjusted fees for pharmacovigilance applications from 18 October 2018, , 18/10/2018
Thu, 18 Oct 2018 10:13 +0100

Pharmacovigilance fees payable to the European Medicines Agency by applicants and marketing authorisation holders increase by 1.7% as of 18 October 2018, to reflect the inflation rate adjustments of 2017.

All applications received by or having a data lock point (DLP) of 17 October 2018 will be charged the current fee and reduction rates. Applications received or having a DLP after that date will be charged the adjusted rates.

Further details of the new fee levels are available in the Commission Delegated Regulation (EU) No 2018/1298 amending Regulation (EU) No 658/2014 and the PDF iconExplanatory note on fees

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Related content

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Related documents

New medicine for hereditary angioedema, a rare disease causing swelling beneath the skin , , 19/10/2018
Fri, 19 Oct 2018 11:03 +0100

The European Medicines Agency has recommended granting a marketing authorisation for Takhzyro (lanadelumab), the first monoclonal antibody therapy for the prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older.

HAE is a long-term debilitating disease characterised by attacks of swelling beneath the skin that can occur anywhere in the body, such as in the face, limbs, gut and larynx. It is caused by abnormalities in the gene responsible for the production of C1 esterase inhibitor. This results in low C protein levels in the blood which induce increased kallikrein protein activity and ultimately cause the swelling. When the swelling occurs in the larynx it may be life-threatening as it can obstruct the airways and impede breathing.

Takhzyro is the first monoclonal antibody for the prevention of this disease. It has been designed to recognise and attach to kallikrein proteins, and thereby block the activity of the kallikrein-kinin system and reduce the number of angioedema attacks. Takhzyro is administered subcutaneously every 2-4 weeks, offering an improvement in patient care compared to current alternative therapies which are administered  either intravenously or more frequently via subcutaneous route. Therefore, the Committee for Medicinal Products for Human Use (CHMP) considered that Takhzyro was of major interest for public health and agreed to the applicant’s request for an accelerated assessment of this medicine.

The benefits and safety of Takhzyro were studied in a phase 3 clinical study involving 125 patients. During 26 weeks of treatment, patients who received Takhzyro showed a significant reduction in the total HAE attack rate and severity. The most common adverse reactions were injection site reactions of mild intensity.

Because HAE is a very rare disease which is estimated to affect less than 0.5 in 10,000 people in the EU, Takhzyro was granted an orphan designation in October 2015. As always at time of approval, this orphan designation will now be reviewed by EMA’s Committee for Orphan Medicinal Products (COMP) to determine whether the information available to date allows maintaining Takhzyro’s orphan status and granting this medicine ten years of market exclusivity.

The opinion adopted by the CHMP is an intermediary step on Takhzyro's path to patient access. The opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation. Once the marketing authorisation has been granted, decisions about price and reimbursement will take place at the level of each Member State, taking into account the potential role/use of this medicine in the context of the national health system of that country.


Note: 

  • The applicant for Takhzyro is Shire Pharmaceuticals Ireland Limited.
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First treatment for rare inherited muscle contraction disorders, , 19/10/2018
Fri, 19 Oct 2018 11:02 +0100

The European Medicines Agency has recommended granting a marketing authorisation for Namuscla (mexiletine hydrochloride) for the treatment of adult patients with non-dystrophic myotonia, a group of inherited muscle disorders where muscles are slow to relax after contraction. These disorders are chronic life-long debilitating conditions characterised by pain, fatigue, and muscle stiffness, resulting in frequent falls and disability.

This is the first time that a treatment for certain forms of myotonic disorders could be authorised EU-wide. The active substance mexiletine has been approved for treatment of these disorders in France only since 2010. Non-dystrophic myotonia is caused by abnormalities in the ion channels, tiny pores in the muscle cells that control the passage of charged particles (ions) such as sodium or chloride and play a key role in the contraction and relaxation of muscles.

Mexiletine is a known antiarrhythmic medicine (used to restore normal heart rhythm), which was first authorised in Europe in the 1970s. It works by blocking ion channels for sodium ions in muscle cells. These sodium channels play a role in the contraction and relaxation of muscles and by blocking them, the medicine helps to reduce the rate of contractions as well as the stiffness that occurs when the contractions are prolonged.

The opinion from the Committee for Medicinal Products for Human Use (CHMP) is based on data from one phase 3 clinical trial in patients with non-dystrophic myotonia as well as data from the literature. These data show that treatment with mexiletine allows relieving stiffness in the muscles. The medicine’s safety profile is well-established; the most common unfavourable effects with this medicine were gastrointestinal disorders, such as heartburn, nausea, vomiting, diarrhoea and abdominal pain. Another less frequently occurring side effect of mexiletine is that it can also trigger arrhythmia or aggravate an existing arrhythmia; the CHMP therefore agreed on specific measures to minimise this risk such as certain contraindications and cardiac monitoring.

Namuscla was designated as an orphan medicinal product in November 2014. As always at time of approval, EMA's Committee for Orphan Medicinal Products (COMP) will review the orphan designation to determine whether the information available to date allows maintaining Namuscla’s orphan status.

The opinion adopted by the CHMP is an intermediary step on Namuscla’s path to patient access. The CHMP opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation. Once a marketing authorisation has been granted, decisions about price and reimbursement will take place at the level of each Member State, taking into account the potential role/use of this medicine in the context of the national health system of that country.


Note:

  • The applicant for Namuscla is Lupin Europe GmbH.
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 October 2018, , 19/10/2018
Fri, 19 Oct 2018 11:04 +0100

The CHMP recommended six medicines for approval, three extensions of indications and elected its new vice-chair at its October 2018 meeting.

Six medicines recommended for approval, including two orphan medicines1

The CHMP recommended granting a marketing authorisation for Takhzyro (lanadelumab), the first monoclonal antibody therapy for the prevention of recurrent attacks of hereditary angioedema (HAE). This medicine was reviewed under EMA's accelerated assessment procedure, reserved for medicines of major public health interest. For more information, please see the press release in the grid below.

The Committee recommended granting a marketing authorisation for Namuscla (mexiletine hydrochloride), for the treatment of myotonia in adult patients with non-dystrophic myotonic disorders. This is the first treatment for this disease to be authorised EU-wide. For more information, please see the press release in the grid below.

The CHMP recommended granting a marketing authorisation for Dengvaxia (dengue tetravalent vaccine (live, attenuated)), the first vaccine in the EU for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4 in people who are between 9 and 45 years old, live in an endemic area and already had a prior dengue virus infection. For more information, please see the press release in the grid below.

The Committee adopted a positive opinion for Flucelvax Tetra (influenza vaccine surface antigen inactivated prepared in cell cultures), intended for the prevention of influenza in adults and children from 9 years of age.

The CHMP also recommended the granting of a marketing authorisation for Bevespi Aerosphere (glycopyrronium / formoterol fumarate dihydrate), for maintenance treatment of chronic obstructive pulmonary disease (COPD).

The biosimilar medicine Ogivri (trastuzumab) received a positive opinion from the CHMP for the treatment of breast and gastric cancer.

Three recommendations on extensions of therapeutic indication

The Committee recommended extensions of indication for Kalydeco, Keytruda and NovoSeven.

CHMP elects new vice-chair

The Committee elected Professor Bruno Sepodes from Portugal as its new vice-chair, for a three-year mandate, starting on 15 October 2018. Professor Sepodes replaces Dr Harald Enzmann, who was elected as CHMP Chair at the September 2018 CHMP meeting. Bruno Sepodes is a member of the evaluation board of medicines at the Portuguese national competent authority - the National Authority for Medicines and Health Products (INFARMED). He has been a member of the CHMP since 2012. In parallel to his involvement in the CHMP, he was also the Chair of EMA’s Committee for Orphan Medicinal Products (COMP) from 2012 to 2018.

Agenda and minutes

The agenda of the October 2018 meeting is published on EMA's website. Minutes of the September 2018 CHMP meeting will be published in the coming weeks.

CHMP statistics

Key figures from the September 2018 CHMP meeting are represented in the graphic below.


1As always at time of approval, these orphan designations will now be reviewed by EMA's Committee for Orphan Medicinal Products (COMP) to determine whether the information available to date allows maintaining the medicines' orphan status and granting the medicines ten years of market exclusivity.

 October 2018

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Positive recommendations on new medicines

Name of medicine Bevespi Aerosphere 
International non-proprietary name (INN) glycopyrronium / formoterol fumarate dihydrate
Marketing-authorisation applicant AstraZeneca AB
Therapeutic indication

Indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD)

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Name of medicine Dengvaxia
Common name dengue tetravalent vaccine (live, attenuated)
Marketing-authorisation applicant Sanofi Pasteur
Therapeutic indication For the prevention of dengue caused by dengue virus serotypes 1, 2, 3 and 4 in people who are between 9 and 45 years old, live in an endemic area and already had a prior dengue virus infection.
More information First vaccine for prevention of dengue
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Name of medicine Flucelvax Tetra 
Common name influenza vaccine surface antigen inactivated prepared in cell cultures
Marketing-authorisation applicant Seqirus Netherlands B.V.
Therapeutic indication

Prophylaxis of influenza in adults and children from 9 years of age. 

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Name of medicine Namuscla
INN mexiletine hcl
Marketing-authorisation applicant Lupin Europe GmbH
Therapeutic indication Symptomatic treatment of myotonia in adult patients with non-dystrophic myotonic disorders
More information First treatment for rare inherited muscle contraction disorders
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Name of medicine Ogivri
INN trastuzumab
Marketing-authorisation applicant MYLAN S.A.S
Therapeutic indication

Treatment of metastatic and early breast cancer and metastatic gastric cancer (MGC)

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Name of medicine Takhzyro
INN lanadelumab 
Marketing-authorisation applicant Shire Pharmaceuticals Ireland Limited
Therapeutic indication

Treatment of angioedema attacks, prevention of angioedema attacks

More information New medicine for hereditary angioedema, a rare disease causing swelling beneath the skin
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Positive recommendations on extensions of therapeutic indications

Name of medicine Kalydeco
INN ivacaftor
Marketing-authorisation applicant

Vertex Pharmaceuticals (Europe) Ltd

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Name of medicine Keytruda
INN pembrolizumab
Marketing-authorisation applicant

Merck Sharp & Dohme B.V.

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Name of medicine NovoSeven 
INN eptacog alfa (activated)
Marketing-authorisation applicant

Novo Nordisk A/S

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Outcomes of arbitration procedures

Name of medicine Paclitaxel Hetero 
INN
 
paclitaxel, 6 mg/ml concentrate for solution for infusion
Marketing-authorisation applicant

Hetero Europe S.L.

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Name of medicine Perlinring 0.120mg/0.015mg per 24 hours Vaginal Delivery System
INN etonogestrel and ethinylestradiol
Marketing-authorisation applicant

Actavis Group PTC EHF

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Other updates

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First vaccine for prevention of dengue, , 19/10/2018
Fri, 19 Oct 2018 11:00 +0100

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorisation for Dengvaxia (dengue tetravalent vaccine (live, attenuated)), for the prevention of dengue caused by dengue virus serotypes 1, 2, 3 and 4 in people who are between 9 and 45 years old, live in an endemic area and already had a prior dengue virus infection.

Dengue is caused by a virus which is transmitted by Aedes mosquitoes, a type of mosquito that is widely spread in tropical and subtropical regions. Most people who contract the disease experience mild, flu-like symptoms. However, around two percent of people affected will develop severe dengue, a potentially lethal complication that includes dengue haemorrhagic fever and/or dengue shock syndrome. Main risk factors for severe dengue include young age and chronic diseases. Secondary infection, in the form of two sequential infections by different serotypes, is also a risk factor for severe disease.

There are four types of dengue virus and people living in a dengue-endemic area can have several dengue infections in their lifetime. No specific treatments for dengue exist and prevention is mainly limited to the environmental management of mosquitoes. There is currently no vaccine available for dengue in the EU.

Dengue is by far the most common mosquito-borne viral disease affecting people worldwide (mainly in tropical areas); tens of millions of cases occur each year resulting in approximately 20,000-25,000 deaths, mainly in children1.

The approved indication excludes the populations of the EU mainland and territories outside tropical areas since dengue is not endemic in these regions. However, a number of EU territories, mainly overseas, are situated in endemic areas, and these territories could benefit from this vaccine.

The benefits and safety of Dengvaxia have been evaluated in 31 clinical studies conducted mostly in dengue endemic areas (Latin America and Asia Pacific). Together, these trials included over 41,000 participants aged 9 months to 60 years receiving at least one dose of the vaccine. The overall available data demonstrate that for people between 9 and 45 years of age, the vaccine has positive effects in preventing symptomatic and severe dengue disease in people who have had previous dengue infection and live in endemic areas. In people who have never had dengue, there is an increased risk of clinically severe dengue disease leading to hospitalisation when vaccinees are subsequently infected with dengue virus. The CHMP therefore recommends limiting the use of the vaccine to individuals with prior dengue virus infection, for whom laboratory confirmation of the previous infection is available before vaccination. In addition, because there are no safety, immunogenicity or efficacy data to support vaccination of individuals living in non-endemic areas and travelling to endemic areas, vaccination of these individuals is not recommended.

A number of additional risk minimisation measures will be put in place, such as educational material for physicians and a guide for healthcare professionals. Use of the vaccine should be according to official recommendation from Member States.

The opinion adopted by the CHMP is an intermediary step on Dengvaxia’s path to patient access. The CHMP opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation. Once a marketing authorisation has been granted, decisions about price and reimbursement will take place at the level of each Member State, taking into account the potential role/use of this medicine in the context of the national health system of that country.


Note

The applicant for Dengvaxia is Sanofi Pasteur.

1https://ecdc.europa.eu/en/dengue-fever/facts/factsheet

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Contact point

EMA press office
Tel. +44 (0)20 3660 8427
E-mail: press@ema.europa.eu
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Regulatory update - EMA encourages companies to submit type I variations for 2018 by end of November 2018, , 26/10/2018
Fri, 26 Oct 2018 13:19 +0100

The European Medicines Agency (EMA) is advising marketing authorisation holders to submit type IAIN and type IA variations for 2018 no later than Friday 30 November 2018. This will enable EMA to acknowledge the validity of the submissions before the Agency's closure between 21 December 2018 and 2 January 2019 and within the 30-day timeframe set out in Article 14 of Commission Regulation (EC) No 1234/2008.

Marketing authorisation holders planning to report Brexit-related Type IA/IAIN variations in December 2018 will receive the acknowledgment of the validity of the submissions within 30 days as per the usual procedure.

Marketing authorisation holders are advised to submit any type IB variations or groupings of type IBs and type IAs by 7 December 2018 for a start of procedure in 2018. For submissions received on or after 10 December 2018, the procedure may not start until January 2019.

For procedural or regulatory queries related to these procedures for human medicines, marketing authorisation holders can send an email to: iaquery@ema.europa.eu or ibquery@ema.europa.eu. For veterinary medicines, the following e-mail address should be used: vet.applications@ema.europa.eu.

Type I variations are minor changes to the marketing authorisation of a medicine.

Type IAIN and IA variations have no impact on the quality, safety or efficacy of the medicine. Type IAIN variations must be notified to the national competent authority or EMA immediately following implementation, in order to ensure the continuous supervision of the medicine. Type IA variations do not require immediate notification and should be notified to the national competent authority or the EMA within 12 months of implementation, or earlier in certain cases.

Type IB variations must be notified to the national competent authority or the EMA before implementation, but do not require a formal approval. Upon acknowledgement of receipt of a valid notification, the marketing authorisation holder must wait for a period of 30 days to ensure that the notification is deemed acceptable by the national competent authority or EMA before implementing the change.

EMA experts awarded for excellence in standards development, , 26/10/2018
Fri, 26 Oct 2018 16:29 +0100

Five EMA staff members – Paolo Alcini, Sabine Brosch, Tim Buxton, Ilaria Del Seppia and Panagiotis Telonis – have won an ISO Excellence Award for their achievements in the development of international standards for the identification of medicinal products (IDMP). The award was presented by Michael Glickman, chair of the International Organization for Standardization (ISO) Technical Committee for Health Informatics at the ISO plenary meeting on 22 October 2018 in Paestum, Italy.

These standards facilitate the exchange of information about medicines between regulators, worldwide data sources and pharmaceutical companies. They provide the basis for the unambiguous identification of medicines worldwide, which will strengthen regulatory activities and in particular improve the continuous monitoring of the medicines’ safety after they have entered the market.

 “I congratulate my colleagues for their invaluable work and major contribution to global standardisation,” said Guido Rasi, EMA’s Executive Director. “Internationally accepted IDMP standards enable the efficient exchange of information on medicines and will improve pharmacovigilance and safety monitoring that we carry out to ensure patient safety.”

Research, development and production of medicines are global. However, regulatory requirements applying to medicines are fragmented as they are developed by various national regulators, resulting in different processes and operating models. This is further complicated by the use of multiple languages, different terminologies and data models, as well as different technical standards for information exchange.

EMA’s team was supported in their efforts by other EMA staff and experts from across the EU. They were part of a global collaborative effort led by ISO, involving medical experts from 32 participating and 27 observing countries who developed a set of five international IDMP standards. These standards provide common formats, data structures, quality criteria and terminologies to identify medicines and exchange information between worldwide regulators and healthcare communities. ISO IDMP covers the entire product lifecycle: medicines in development, medicines under evaluation and authorised products.

EMA is implementing the ISO IDMP standards in phases through its SPOR programme. With SPOR, EMA is delivering a set of master data management services for pharmaceutical and regulatory data relating to substances, products, organisations and referentials (SPOR) to enable consistent reuse in EMA’s multiple business cases.

Referential and organisation services were delivered and are already used in regulatory applications and business processes, such as electronic application forms (eAF), the orphan medicines application portal (IRIS) or the EudraVigilance (EV) user registration process. This is followed by the iterative implementation of products and substance data services.

EMA closed 1-2 November 2018, , 30/10/2018
Tue, 30 Oct 2018 09:55 +0000

EMA is closed from 18:30 on Wednesday 31 October until 7:30 on Monday 5 November 2018.

Outside of working hours and on public holidays, it is possible to call the product emergency hotline on +44 (0)20 3660 7600. Please note that this is an emergency number and should only be used in the event of a potentially serious problem with a centrally authorised product.

Working with stakeholders to improve availability of medicines in the EU, , 31/10/2018
Wed, 31 Oct 2018 11:15 +0000

The task force set up by EMA and the Heads of Medicines Agencies (HMA) on availability of authorised human and veterinary medicines is organising a two-day workshop (8-9 November 2018) at EMA in London to gather stakeholders' perspectives on how to better address potential problems with the supply of medicines and how to avoid shortages of medicines.

Improving the availability of human and veterinary medicines authorised in the EU is a key priority of the European medicines regulatory network. The aim of the task force is to develop and coordinate actions for better prevention, identification, management of and communication on issues that can affect availability of medicines, in order to improve continuity of supply of human and veterinary medicines across Europe. In the context of the potential supply disruption of medicines following the UK’s withdrawal from the EU, the task force serves as a platform to facilitate and coordinate actions between Member States, EMA and the European Commission.

The task force’s work programme for the coming two years was published in August 2018.

Day 1 of the workshop is a technical meeting with industry stakeholders to focus on the pharmaceutical industry’s critical role in the prevention and management of medicine shortages. Industry stakeholders are invited to give their feedback on the technical implications of some of the actions set out in the work plan of the task force in the field of human medicines and to present best practices already developed for the prevention of shortages.

Day 2 of the workshop will bring together regulators, industry representatives, healthcare professionals, patients and consumers, academia and NGOs. The purpose of this second day is to obtain the views of all stakeholders on the work of the task force and to discuss how the different stakeholder groups can contribute to the actions in the workplan. The workshop will mainly focus on human medicines; however, issues common to both human and veterinary medicines will be addressed in the context of Brexit.

The workshop is by invitation only, but day 2 will be broadcast live on EMA’s website. Agendas for both days are available.

The task force consists of representatives from EMA, the European Commission and national competent authorities, the chairs of the Co-ordination Groups for Mutual Recognition and Decentralised Procedures – Human (CMDh) and Veterinary (CMDv), the GMP/GDP Inspections Working Party, the HMA Working Group of Communication Professionals (WGCP) and the European Surveillance Strategy Working Group (ESS WG).

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Meeting highlights from EMA’s safety committee (PRAC) 29-31 October 2018, , 31/10/2018
Wed, 31 Oct 2018 13:51 +0000

At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities, which cover all aspects of the risk management of the use of medicines: assessment of signals, risk management plans, periodic safety update reports and post-authorisation safety studies.

The Committee did not start or conclude any referral procedures. More information on all safety reviews currently under evaluation is provided in the ‘Ongoing referrals’ table.

Information on all topics discussed by the PRAC is available in the agenda below. A record of the discussions held this week will be provided in the minutes of this meeting, which will be published following the next PRAC meeting at the end of November.

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Agenda

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Ongoing referrals

Procedure

Status

Update

Article-31 procedure: Methotrexate containing medicinal products

Under evaluation

PRAC continued assessment.

Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 6-8 November 2018, , 09/11/2018
Fri, 09 Nov 2018 15:30 +0000

CVMP opinions on veterinary medicinal products

The Committee adopted by consensus a positive opinion for an initial marketing authorisation application for Isemid (torasemide), from CEVA Santé Animale, a new cardiovascular product intended for treatment of clinical signs related to congestive heart failure in dogs, including pulmonary oedema.

The Committee adopted by consensus a positive opinion for an initial marketing authorisation application for Syvazul BTV, from LABORATORIOS SYVA, S.A.U., a vaccine for the active immunisation of sheep to prevent viraemia and reduce clinical signs and lesions caused by bluetongue virus serotypes 1 and/or 8, and/or to reduce viraemia and clinical signs caused by bluetongue virus serotype 4; and of cattle to prevent viraemia caused by bluetongue virus serotypes 1 and/or 8 and/or to reduce viraemia caused by bluetongue virus serotype 4.

The Committee adopted by consensus a positive opinion for a type II variation application for Aftovaxpur DOE concerning a change to the onset of immunity in cattle and sheep.

More information about the above mentioned medicines, including their full indications, will be published on the Agency’s website.

Renewals of marketing authorisation

The Committee adopted by consensus positive opinions for the renewal of the marketing authorisations for Loxicom and Parvoduk. The Committee, having re-assessed the benefit-risk balance of these products, concluded that the quality, safety and efficacy continue to be appropriately demonstrated and, therefore, recommended the renewals of the marketing authorisations. Based on pharmacovigilance grounds (limited data) the Committee concluded that a further 5-year renewal was necessary for Parvoduk. An indefinite authorisation was recommended for Loxicom.

Community referrals and related procedures

The Committee concluded a procedure concerning the need for inclusion of a maximum limit for histamine in the active substance and/or finished product specifications for veterinary medicinal products containing gentamicin for parenteral administration to horses. The procedure responds to a request from the European Medicines Agency Executive Director for the Committee to give a scientific opinion under Article 30(3) of Regulation 726/2004 in connection with adverse reactions seen in horses following use of gentamicin solution for injection. The adverse reactions were considered to be linked to histamine residues present in the active substance. The Committee adopted by consensus an opinion concluding that, where relevant, a maximum limit for histamine should be included in the specification for the active substance gentamicin. In addition, the Committee has made recommendations to the European Directorate for the Quality of Medicines (EDQM), active substance manufacturers and marketing authorisation holders.

The opinion and assessment report will be published on the Agency’s website.

Scientific advice

The Committee adopted two scientific advice reports further to requests for:

  • initial advice on quality, safety and efficacy issues for a new immunological veterinary medicinal product for dogs;
  • initial advice on safety and efficacy issues for a new immunological veterinary medicinal product for chickens.

Minor use, minor species (MUMS)/limited market

Following the Committee’s review of a request for classification under the MUMS/limited market policy, the CVMP classified an indication in a veterinary medicinal product (antiparasitics, insecticides and repellents) for cats as indicated for MUMS/limited market and eligible for reduced data requirements. The product is not eligible for financial incentives as it is intended for use in non-food producing species.

Following the Committee’s review of a request for reclassification under the MUMS/limited market policy, the CVMP reclassified an immunological product for foxes and raccoon dogs as intended for a MUMS/limited market and eligible for reduced data requirements, where applicable. The product is not eligible for financial incentives.

Pharmacovigilance

The Committee reviewed the PSURs for Acticam, EQUIOXX, Fevaxyn Pentofel, Halagon, Rabitec, Trifexis, Velactis, Versican Plus DHPPI L4 and Versican Plus DHPPi L4R and concluded that no changes to their product information or other regulatory action were required.

The Committee also reviewed the PSURs for MiPet Easecto, Simparica and Zycortal and recommended amendments to the product information.

Concept papers, guidelines and SOPs

Quality

The Committee adopted a draft reflection paper on risk management requirements for elemental impurities in veterinary medicinal products (EMA/CVMP/QWP/153641/2018) for public consultation until 31 August 2019. This new reflection paper has been developed to address the requirements to control elemental impurities in veterinary medicinal products, as a result of updates in the European Pharmacopoeia General Monograph 2619 for pharmaceutical preparations. The Committee also adopted revised timelines for the implementation of risk assessment requirements to control elemental impurities in veterinary medicinal products (EMA/CVMP/QWP/631010/2017).

Both the draft reflection paper and the timelines for implementation document will be published on the Agency’s website.

The Committee adopted the revised guideline on active substance master file procedure (EMEA/CVMP/134/02 Rev 4). The update is intended to clarify the responsibilities of the applicant/marketing authorisation holder in the provision of information related to active substances.

The revised guideline will be published on the Agency’s website.

The Committee adopted a question and answer on requirements for selection and justification of starting materials for the manufacture of chemical active substances in veterinary medicinal products.

The question and answer will be published on the Agency’s website.

Environmental Risk Assessment

The Committee adopted a draft reflection paper (EMA/CVMP/ERA/632109/2014) on antimicrobial resistance in the environment for a nine-month period of public consultation. This draft reflection paper has examined key sources and pathways relevant to the release of antimicrobials in the environment from the use of antimicrobial veterinary medicinal products, including the potential transport of antimicrobial resistance genes. The paper considers the suitability of the current environmental risk assessment for characterising the potential risks posed by antimicrobial resistance genes, and concludes in a series of recommendations to improve the understanding of the impact to animal and human health of antimicrobials in the environment resulting from the use of veterinary medicinal products.

The document will be published on the Agency’s website.

Antimicrobials

The Committee adopted a reflection paper on off-label use of antimicrobials in veterinary medicine in the European Union (EMA/CVMP/AWP/237294/2017). The reflection paper aims to explore the potential risks related to antimicrobial resistance associated with the use of antimicrobial in veterinary medicine which does not comply with the approved summary of product characteristics.

The reflection paper together with the overview of comments (EMA/CVMP/EWP/30098/2018) will be published on the Agency’s website.

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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 November 2018, , 16/11/2018
Fri, 16 Nov 2018 12:00 +0000

EMA’s human medicines committee (CHMP) recommended four medicines for approval, including a medicine for use in countries outside the European Union, at its November 2018 meeting.

The CHMP adopted a positive opinion for Fexinidazole Winthrop (fexinidazole), the first oral-only medicine (tablets) for the treatment of human African trypanosomiasis, commonly known as sleeping sickness, due to Trypanosoma brucei gambiense. This is the tenth medicine recommended by EMA under Article 58, a mechanism that allows the CHMP to assess and give opinions on medicines for use outside the European Union. For more information, please see the press release in the grid below.

Erleada (apalutamide) received a positive opinion for the treatment of non-metastatic castration resistant prostate cancer.

The CHMP recommended granting a marketing authorisation for Macimorelin Aeterna Zentaris (macimorelin), for the diagnosis of growth hormone deficiency in adults.

The generic medicine Silodosin Recordati (silodosin) received a positive opinion from the CHMP for the treatment of the signs and symptoms of benign prostatic hyperplasia.

Four recommendations on extensions of therapeutic indication

The Committee recommended extensions of indication for Kisqali, Mabthera, Orkambi and Ravicti.

Positive recommendations on extension of therapeutic indication following re-examination

The Committee recommended an extension of therapeutic indication for Blincyto (blinatumomab) in patients with residual cancer cells in the body after previous treatment, after re-examining its negative opinion for this medicine adopted in July 2018.

The CHMP also adopted a positive opinion for the use of Opdivo (nivolumab) and Yervoy (ipilimumab) in combination to treat renal cell carcinoma (kidney cancer), after re-examining its negative opinion adopted in July 2018.

For more information on these positive opinions following re-examination please see the question-and-answer documents in the grid below.

Outcome of review on quinolone and fluoroquinolone antibiotics

The CHMP recommended suspending some quinolone and fluoroquinolone antibiotics and introducing changes including restrictions on the use of all others following a review of disabling and potentially permanent side effects reported with these medicines. The review incorporated the views of patients, healthcare professionals and academics presented at EMA’s public hearing on these medicines in June 2018. For more information, please see the public health recommendation in the grid below.

Withdrawal of extension of indication application

The application to extend the use of Tecentriq (atezolizumab) to treat kidney cancer was withdrawn. A question-and-answer document on this withdrawal is available in the grid below.

Agenda and minutes

The agenda of the November 2018 meeting is published on EMA's website. Minutes of the October 2018 CHMP meeting will be published in the coming weeks.

CHMP statistics

Key figures from the November 2018 CHMP meeting are represented in the graphic below.

 November 2018

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Positive recommendations on new medicines

Name of medicine Erleada
INN apalutamide
Marketing-authorisation applicant Janssen-Cilag International N.V.
Therapeutic indication Treatment of non-metastatic castration resistant prostate cancer
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Name of medicine Macimorelin Aeterna Zentaris
INN macimorelin
Marketing-authorisation applicant Aeterna Zentaris GmbH
Therapeutic indication Diagnosis of growth hormone deficiency in adults
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Positive recommendation on new generic medicine

Name of medicine Silodosin Recordati
INN silodosin
Marketing-authorisation applicant Recordati Ireland Ltd
Therapeutic indication Treatment of the signs and symptoms of benign prostatic hyperplasia
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Positive recommendation on medicine for use outside the European Union

Name of medicine Fexinidazole Winthrop
INN fexinidazole
Opinion holder sanofi-aventis groupe
Therapeutic indication Treatment of human African trypanosomiasis (HAT) due to Trypanosoma brucei gambiense
More information Press release: CHMP recommends first oral-only treatment for sleeping sickness
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Positive recommendations on extensions of indications

Name of medicine Kisqali
INN ribociclib
Marketing-authorisation applicant

Novartis Europharm Limited

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Name of medicine Mabthera
INN rituximab
Marketing-authorisation applicant Roche Registration GmbH
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Name of medicine Orkambi
INN lumacaftor / ivacaftor
Marketing-authorisation applicant Vertex Pharmaceuticals (Europe) Ltd
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Name of medicine Ravicti
INN glycerol phenylbutyrate
Marketing-authorisation applicant Horizon Pharma Ireland Limited
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Positive recommendations on extensions of indications following re-examination

Name of medicine Blincyto
INN blinatumomab
Marketing-authorisation applicant Amgen Europe B.V.
, , ,

 

Name of medicine Opdivo
INN nivolumab
Marketing-authorisation applicant Bristol-Myers Squibb Pharma EEIG
, , ,

 

Name of medicine Yervoy
INN ipilimumab
Marketing-authorisation applicant Bristol-Myers Squibb Pharma EEIG
, , ,

Public-health recommendation

Name of medicine Quinolone- and fluoroquinolone-containing medicinal products
INN nalidixic acid, pipemidic acid, cinoxacin, enoxacin, pefloxacin, lomefloxacin, ciprofloxacin, levofloxacin, ofloxacin, moxifloxacin, norfloxacin, prulifloxacin, rufloxacin, flumequin
More information Disabling and potentially permanent side effects lead to suspension or restrictions of quinolone and fluoroquinolone antibiotics
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Outcomes of arbitration procedures

Name of medicine Diclofenac sodium spray gel 4%
INN diclofenac
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Name of medicine Diotop capsules
INN diclofenac / omeprazole

 

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Withdrawal of extension of indication application

Name of medicine Tecentriq
INN atezolizumab
Marketing-authorisation applicant Roche Registration GmbH
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Other updates

EMA’s Brexit plans ensure Agency’s focus on medicines evaluation and supervision, , 13/11/2018
Tue, 13 Nov 2018 16:00 +0000

A PDF iconreport on EMA’s 24 September 2018 meeting with industry stakeholders to discuss the UK’s withdrawal from the European Union and the impact on the operation of the centralised procedure for human and veterinary medicines, published today, outlines how the European medicines regulatory network is preparing for Brexit, including EMA’s relocation and business continuity planning.

At the meeting, participants were updated on EMA’s Brexit preparedness plans, which ensure that all core activities related to the evaluation and supervision of medicines continue uninterrupted, and to the same quality and timelines during the Agency’s relocation to Amsterdam and throughout 2019. With the exception of some delays in processing of EMA certificates, there should be no impact on other EMA procedures (e.g. scientific advice, orphan designation, paediatric investigation plans (PIPs), applications for marketing authorisation, post-authorisation activities). Companies are advised to submit applications and requests as normal.

The Agency entered PDF iconphase 3 of its Brexit preparedness business continuity plan (BCP) on 1 October 2018, with the temporary suspension or reduction of some additional activities, including the scaling back of guideline development and revision, and the temporary putting on hold of non-product-related working parties. These steps have been taken to ensure that EMA can focus on its core business of protecting human and animal health and that freed-up resources can be redeployed to allow the Agency to safeguard its core activities related to the evaluation and supervision of medicines.

The meeting was organised by EMA together with the European Commission and was attended by a broad range of industry stakeholders. Participants were again encouraged to submit all Brexit-related variation applications before end of 2018 to ensure that their marketing authorisations are compliant with EU pharmaceutical legislation before the departure of the UK from the EU.

A further three industry stakeholder meetings on Brexit are planned for 2019.

EMA gives guidance on safety monitoring of medicines used in children, , 13/11/2018
Tue, 13 Nov 2018 12:30 +0000

EMA has published the new good pharmacovigilance practice (GVP) chapter IV on specific considerations for the paediatric population. It offers a holistic view of paediatric pharmacovigilance and provides guidance on how to make best use of existing tools and processes to address the specific needs and challenges of safety monitoring of medicines used in children. In addition it advises on how to adapt regulatory requirements to the paediatric population in the European Union.

The new GVP chapter covers approved medicines with a paediatric indication or with an ongoing paediatric development, but also medicines only approved for adults when they are used off-label to treat children, i.e. for a medical purpose not in accordance with the terms of the marketing authorisation.

A dedicated approach to pharmacovigilance in children is especially important given that paediatric clinical trials are often limited in size and duration, and adverse reactions in children may substantially differ - in terms of frequency, nature, severity and presentation - from those occurring in adults.

The guidance focuses on aspects of pharmacovigilance of particular relevance to the use of medicines in children, such as off-label use and medication errors, and contains paediatric-specific guidance on all major pharmacovigilance tools and processes, including risk management plans, periodic safety update reports, post-authorisation safety studies, signal management and safety communication.

It also highlights the need to include comprehensive information in adverse drug reaction reports, such as the child’s age, weight and height, as well as, the indication or intention of use of the medicine, including its strength, dose and pharmaceutical form. This is important for all actors involved in safety reporting of medicines in children, including pharmaceutical companies, sponsors of clinical studies and regulatory authorities, but also parents/carers, healthcare professionals, patient and healthcare professional organisations, and organisations of national healthcare systems.

The new GVP chapter was finalised after careful consideration of the extensive feedback received during a public consultation, and replaces EMA’s human medicines committee’s (CHMP) 2007 guideline on conduct of pharmacovigilance for medicines used by the paediatric population.

CHMP recommends first oral-only treatment for sleeping sickness, , 16/11/2018
Fri, 16 Nov 2018 11:59 +0000

EMA’s human medicines committee (CHMP) has adopted a positive opinion for Fexinidazole Winthrop (fexinidazole), the first oral-only medicine (tablets) for the treatment of human African trypanosomiasis (HAT), commonly known as sleeping sickness, due to Trypanosoma brucei gambiense.

This is the tenth medicine recommended by EMA under Article 58, a mechanism that allows the CHMP to assess and give opinions on medicines that are intended for use in countries outside the European Union.

HAT is a life-threatening, neglected tropical disease that is endemic in sub-Saharan Africa. There are two forms of sleeping sickness, depending on the parasite involved: Trypanosoma brucei gambiense or Trypanosoma brucei rhodesiense. The vast majority (98%) of reported cases are caused by T. b. gambiense. Most cases occur in the Democratic Republic of the Congo, with the remainder located in bordering central African countries.

HAT caused by T. b. gambiense is characterised by a more chronic disease evolution. Within a few weeks of infection, patients can experience bouts of fever, headaches, joint and muscle pains and itching. Over time the disease invades the central nervous system. Patients display neurological signs including mental confusion, slurred speech, seizures, difficulty in walking and talking and worsening sleep disturbances. If left untreated, the disease is usually fatal within a time span of two to three years.

Current therapy is selected based on how much the central nervous system is affected. Treatments include intramuscular injections of pentamidine, which are painful and only adequate for the earlier stage of the disease. Other treatments are available, e.g. a combination of oral nifurtimox and intravenous infusion of eflornithine (NECT) as reference therapy when the disease has advanced and affects the central nervous system. However, all these treatments require a minimum health infrastructure and personnel, not readily available in some remote areas.

Fexinidazole Winthrop, as exclusively oral treatment regimen for the disease, could potentially allow quicker and wider access to treatment because distribution and administration of tablets is easier. It was developed by the applicant in partnership with the Drugs for Neglected Diseases initiative, a non-profit drug research and development organisation based in Switzerland.

The benefits and safety of Fexinidazole Winthrop were evaluated in three clinical studies involving 749 patients across the different stages of the disease. The studies showed high cure rates in patients after ten days of treatment, especially in the earlier stage of the disease. However, for patients whose central nervous system is already severely affected, Fexinidazole should only be given under strict supervision in hospital when no other adequate treatment is available or tolerated.

The most common side effects observed were vomiting, nausea, headache, insomnia, weakness, dizziness and tremor.

Because there were a small number of cases of late relapse in the studies, the CHMP recommends a follow-up monitoring of up to 24 months to ensure the surveillance of potential relapses. All eligible patients should receive Fexinidazole under supervision of trained healthcare staff to ensure full compliance.

Fexinidazole Winthrop was submitted to EMA under a regulatory procedure (Article 58) which allows the Agency to assess the quality, safety and efficacy of a medicine and give an opinion on its benefit-risk balance when used in low- and middle-income countries outside the EU. Medicines submitted under this programme are assessed by EMA in collaboration with the World Health Organization (WHO). They must meet the same standards as medicines intended for EU citizens. More information is available on the  PDF iconinfographic on Article 58 procedure .

The scientific opinion from the CHMP helps to support regulators in countries where regulatory capacity may be limited, by providing an expert evaluation of the medicine when used in local practice. National regulators can use the CHMP's scientific assessment to decide on the use of the medicine in their countries.

Notes

The applicant for Fexinidazole Winthrop is sanofi-aventis groupe.

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Disabling and potentially permanent side effects lead to suspension or restrictions of quinolone and fluoroquinolone antibiotics , , 16/11/2018
Fri, 16 Nov 2018 12:19 +0000

EMA has reviewed serious, disabling and potentially permanent side effects with quinolone and fluoroquinolone antibiotics given by mouth, injection or inhalation. The review incorporated the views of patients, healthcare professionals and academics presented at EMA’s public hearing on fluoroquinolone and quinolone antibiotics in June 2018.

EMA’s human medicines committee (CHMP) has endorsed the recommendations of EMA’s safety committee (PRAC) and concluded that the marketing authorisation of medicines containing cinoxacin, flumequine, nalidixic acid, and pipemidic acid should be suspended.

The CHMP confirmed that the use of the remaining fluoroquinolone antibiotics should be restricted. In addition, the prescribing information for healthcare professionals and information for patients will describe the disabling and potentially permanent side effects and advise patients to stop treatment with a fluoroquinolone antibiotic at the first sign of a side effect involving muscles, tendons or joints and the nervous system.

Restrictions on the use of fluoroquinolone antibiotics will mean that they should not be used:

  • to treat infections that might get better without treatment or are not severe (such as throat infections);
  • to treat non-bacterial infections, e.g. non-bacterial (chronic) prostatitis;
  • for preventing traveller’s diarrhoea or recurring lower urinary tract infections (urine infections that do not extend beyond the bladder);
  • to treat mild or moderate bacterial infections unless other antibacterial medicines commonly recommended for these infections cannot be used.

Importantly, fluoroquinolones should generally be avoided in patients who have previously had serious side effects with a fluoroquinolone or quinolone antibiotic. They should be used with special caution in the elderly, patients with kidney disease and those who have had an organ transplantation because these patients are at a higher risk of tendon injury. Since the use of a corticosteroid with a fluoroquinolone also increases this risk, combined use of these medicines should be avoided.

The CHMP opinion will now be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU countries. National authorities will enforce this decision for the fluoroquinolone and quinolone medicines authorised in their countries and they will also take other appropriate measures to promote the correct use of these antibiotics.

Information for patients

  • Fluoroquinolone medicines (which contain ciprofloxacin, levofloxacin, lomefloxacin, moxifloxacin, norfloxacin, ofloxacin, pefloxacin, prulifloxacin and rufloxacin) can cause long-lasting, disabling and potentially permanent side effects involving tendons, muscles, joints and the nervous system.
  • These serious side effects include inflamed or torn tendon, muscle pain or weakness, and joint pain or swelling, walking difficulty, feeling pins and needles, burning pain, tiredness, depression, problems with memory, sleeping, vision and hearing, and altered taste and smell.
  • Tendon swelling and injury may occur within 2 days of starting treatment with a fluoroquinolone but may even occur several months after stopping treatment.
  • Stop taking a fluoroquinolone medicine and contact your doctor at once in the following cases:
    • at the first sign of tendon injury, such as tendon pain or swelling – rest the painful area;
    • if you get pain, feel pins and needles, tingling, tickling, numbness or burning, or weakness especially in the legs or arms;
    • if you get swelling in the shoulder, arms or legs, have walking difficulty, feel tired or depressed or have problems with your memory or with sleeping or you notice changes with your vision, taste, smell or hearing. You and your doctor will decide if you can continue treatment or if you need to take another type of antibiotic.
  • You may be more prone to joint pain or swelling or tendon damage if you are aged over 60 years, your kidneys do not work well or you have received organ transplantation.
  • Speak with your doctor if you are taking a corticosteroid (medicines such as hydrocortisone and prednisolone) or need to have treatment with a corticosteroid. You may be especially prone to tendon damage if you are taking a corticosteroid and a fluoroquinolone medicine at the same time.
  • You should not take a fluoroquinolone medicine if you have ever had a serious side effect with a fluoroquinolone or a quinolone medicine and you should speak with your doctor immediately.
  • If you have any questions or concerns about your medicines, speak to your doctor or pharmacist.

Information for healthcare professionals

  • Fluoroquinolones are associated with prolonged (up to months or years), serious, disabling and potentially irreversible drug reactions affecting several, sometimes multiple, systems, organ classes and senses.
  • The serious side effects include tendonitis, tendon rupture, arthralgia, pain in extremities, gait disturbance, neuropathies associated with paraesthesia, depression, fatigue, memory impairment, sleep disorders, and impaired hearing, vision, taste and smell.
  • Tendon damage (especially to Achilles tendon but also other tendons) can occur within 48 hours of starting fluoroquinolone treatment but the damage may be delayed several months after stopping treatment.
  • Patients who are older, have renal impairment or have had solid organ transplantation and those being treated with a corticosteroid are at higher risk of tendon damage. Concomitant treatment with a fluoroquinolone and a corticosteroid should be avoided.
  • Fluoroquinolone treatment should be discontinued at the first sign of tendon pain or inflammation and patients should be advised to stop treatment with a fluoroquinolone and speak with the doctor in case of symptoms of neuropathy such as pain, burning, tingling, numbness or weakness so as to prevent development of potentially irreversible condition.
  • Fluoroquinolones should generally not be used in patients who have had serious adverse reactions associated with the use of quinolone or fluoroquinolone medicines.
  • Up-to-date summary of product characteristics should be consulted for authorised indications when considering treatment with a fluoroquinolone medicine. This is because the indications for these medicines have been restricted.
  • The benefits and risks of fluoroquinolones will be monitored continuously and a drug utilisation study will evaluate the effectiveness of the new measures to reduce inappropriate use of fluoroquinolones by investigating changes in prescribing behaviour. 

More about the medicine

Fluoroquinolones and quinolones are a class of broad-spectrum antibiotics that are active against bacteria of both Gram-negative and Gram-positive classes. Fluoroquinolones are of value in certain infections, including some life-threatening ones, where alternative antibiotics are not sufficiently effective.

The review covered medicines containing the following fluoroquinolone and quinolone antibiotics: cinoxacin, ciprofloxacin, flumequine, levofloxacin, lomefloxacin, moxifloxacin, nalidixic acid, norfloxacin, ofloxacin, pefloxacin, pipemidic acid, prulifloxacin and rufloxacin.

The review concerned only medicines given systemically (by mouth or injection) and inhaled medicines.

More about the procedure

The review of fluoroquinolones and quinolones was initiated on 9 February 2017 at the request of the German medicines authority (BfArM), under Article 31 of Directive 2001/83/EC.

The review was first carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines.

The final PRAC recommendations were adopted on 4 October 2018 and then sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency’s opinion. The CHMP opinion will now be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States.

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